Prostate Cancer Treatment Protocols
Treatment protocols for prostate cancer are provided below, including general treatment recommendations and those for localized prostate cancer, for recurrent disease, and for advanced or metastatic disease.
See Prostate Cancer: Diagnosis and Staging, a Critical Images slideshow, to help determine the best diagnostic approach for this potentially deadly disease.
Also, see the Advanced Prostate Cancer: Signs of Metastatic Disease slideshow for help identifying the signs of metastatic disease.
Selecting initial treatment requires assessing the risk of the disease spreading or progressing, which is based on evaluating the patient’s life expectancy, comorbidities, biopsy grade (Gleason score), clinical stage, and prostate-specific antigen (PSA) level.
Very low risk of recurrence:
Patients with clinical stage T1c, Gleason score ≤6, PSA </li>
Active surveillance includes periodic PSA testing, digital rectal examination (DRE), and prostate biopsy. The optimal protocol for surveillance is still unknown, [1, 2, 3] but may include PSA as often as every 3 mo or at least every 6 mo, DRE as often as every 6 mo but at least every 12 mo, and repeat biopsy within 18 mo but as often as every 12 mo or if PSA and DRE change [4, 5, 6]
For treatment recommendations for patients with a life expectancy ≥20 y, see initial therapy for Low Risk of Recurrence, below
Low risk of recurrence:
Treatment for patients with clinical stage T1-T2a, Gleason score 2-6, PSA 7</ref>
Treatment for patients with a life expectancy ≥10y includes active surveillance or
Radical prostatectomy (RP) with or without pelvic lymph node dissection (PLND); RP is the standard therapy for localized prostate cancer, involving the removal of the prostate and seminal vesicles with or without pelvic lymph nodes; this may be done using either open or laparoscopic (robotic-assisted) technique [3, 8, 9] or
External beam radiation therapy is a standard therapy for patients with localized disease; 3-dimensional (3D) techniques such as 3D conformal radiation treatment (3D-CRT) offer reduced toxicity and the use of higher doses; second-generation techniques, including intensity-modulated radiation therapy (IMRT), are also required, especially if doses ≥78 Gy are administered 
Patients with low-risk cancer are not candidates for pelvic lymph node irradiation or ADT 
Intermediate risk of recurrence:
Treatment options for patients with clinical stage T2b-T2c, Gleason score 7 or PSA 10-20 ng/mL, who have a life expectancy or</b>
Radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT with daily IGRT with or without short-term neoadjuvant/concomitant/adjuvant ADT for 4-6 mo with or without brachytherapy (recommended dose rate: 145 Gy for iodine-125 and 125 Gy for palladium-103) [13, 14]
Treatment recommendations for patients with a life expectancy ≥10 y include RP with PLND or
Radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT with daily IGRT with or without short-term neoadjuvant/concomitant/adjuvant ADT for 4-6 mo with or without brachytherapy (recommended dose rate: 145 Gy for iodine-125 and 125 Gy for palladium-103)
Intermediate-risk cancers consider combining brachytherapy (recommended dose rate: 145 Gy for iodine-125 and 125 Gy for palladium-103) with external beam radiation therapy (EBRT)(40-50 Gy) with or without 4-6 mo neoadjuvant/concomitant/adjuvant ADT
Administering ADT before, during, and after radiation prolongs survival 
High risk of recurrence:
Clinical stage T3a, Gleason score 8-10, PSA >20 ng/mL
Treatment options include RP plus PLND for selected patients or
Radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT plus long-term neoadjuvant/concomitant/adjuvant ADT for 2-3 y or
Radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT with daily IGRT plus brachytherapy (recommended dose rate: 145 Gy for iodine-125 and 125 Gy for palladium-103) with or without short-term neoadjuvant/concomitant/adjuvant ADT for 4-6 mo or
High-risk cancers may be treated with combination EBRT (40-50 Gy) and brachytherapy with or without 4-6 mo neoadjuvant/concomitant/adjuvant ADT
Other treatments that have been used in the initial management of localized prostate cancer include the following:
Cryotherapy (also known as cryosurgery or cryoablation) involves using transrectal ultrasonographic guidance; percutaneous cryoprobes are placed and used to freeze prostate tissue
This treatment is not preferred as a standard curative treatment option but may be used in select patients with localized prostate cancer or as focal therapy in low-risk patients (experimental) 
Can also be considered as salvage therapy after failed radiation therapy 
Complications include tissue sloughing, perineal ecchymosis, stricture or contracture, incontinence, impotence, and fistula formation between the urinary and gastrointestinal tracts
High-intensity focused ultrasound  :
Particle beam therapy  :
See the list below:
Biopsy of the prostatic bed is usually not recommended unless the patient is a candidate for salvage therapy
Monitor PSA, alkaline phosphatase, and calcium every 6 months to determine whether the doubling time is less than 1 year
See the list below:
Defined as a detectable PSA that increases on two subsequent measurements or a PSA that fails to fall to undetectable levels
PSA that fails to fall to undetectable levels after prostatectomy may indicate residual prostate cancer or prostate cancer
Treatment options include salvage radiation therapy, androgen deprivation, and surveillance
See the list below:
PSA can bounce up and down after radiation
Treatment options include salvage prostatectomy, ADT, surveillance, high-intensity focused ultrasound (clinical trials), cryotherapy, repeat irradiation
Very high risk:
Clinical stage T3b-T4 treatment options include radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT plus long-term neoadjuvant/concomitant/adjuvant androgen deprivation therapy (ADT) for 2-3 y or
Radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT with daily IGRT plus brachytherapy with or without short-term neoadjuvant/concomitant/ADT for 4-6 mo or
RP plus PLND for selected patients (those with clinically localized prostate cancer that can be completely excised surgically, life expectancy of at least 10 years, and no serious comorbid conditions that would contraindicate elective surgery)  or
ADT alone, in patients with T3 disease and/or node-positive disease and PSA doubling time less than 10 months
Nonmetastatic castration-resistant prostate cancer can be treated with apalutamide 240 mg (ie, four 60-mg tablets) PO daily; administer with GnRH analog concurrently, unless the patient has had bilateral orchiectomy 
Any T, N1: Treatment includes ADT or radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT with IGRT plus long-term neoadjuvant/concomitant/adjuvant ADT for 2-3y
Any T, any N, M1: Treatment includes only ADT for patients with M1
See the list below:
ADT is a preferred initial treatment for symptomatic metastatic prostate cancer because androgenic effects promote the growth and malignant transformation of prostatic tissue 
ADTs include luteinizing hormone (LH) receptor agonists (eg, histrelin, leuprolide), gonadotropin-releasing hormone (GnRH) receptor agonists (eg, goserelin, histrelin, leuprolide, triptorelin) and antagonists (eg, degarelix), and complete androgen blockade (CAB)
CAB includes medical castration with an oral antiandrogen (eg, bicalutamide, flutamide, nilutamide) or surgical castration 
Patients who do not show an adequate suppression of serum testosterone (</li>
Monotherapy with nonsteroidal antiandrogens is less effective but these agents are associated with fewer hot flashes and fatigue and do not impair libido
If hormone therapy fails, that therapy should be continued into and through the next hormone manipulation
Gonadotropin-releasing hormone agonists:
Therapy with GnRH analogs may induce medical castration by suppressing luteinizing hormone (LH) production
These agonists can potentially cause a transient surge of LH when therapy is initiated before the LH levels fall (flare phenomenon)
GnRH agonists are offered in 1 mo, 3 mo, and once-yearly depots; premedication with antiandrogen is necessary to prevent flare phenomenon
Leuprolide: 7.5 mg intramuscularly (IM) monthly or 22.5 mg IM every 3 mo or 30 mg IM every 4 mo or 45 mg intravenously (IV) every 6 mo or
Triptorelin: 3.75 mg IM monthly or 11.25 mg IM every 3 mo or 22.5 mg IM every 6 mo
Gonadotropin-releasing hormone antagonists:
Nonsteroidal antiandrogens for non–castrate-resistant disease:
Antiandrogens bind to androgen receptors and competitively inhibit their interaction with testosterone and dihydrotestosterone
These agents do not decrease LH levels and androgen production
Antiandrogens are usually used in combination with a GnRH agonist, to prevent a disease flare caused by the transient increase in testosterone levels
Flutamide 250 mg orally (PO) TID or
Bicalutamide 50 mg PO daily; patients refractory to other antiandrogen agents may start with 150 mg PO daily or
Nilutamide 300 mg PO daily for 30 days, and then 150 mg PO daily or
Enzalutamide (160 mg PO daily), which was previously indicated only for metastatic castration-resistant prostate cancer in patients who had received docetaxel; it is now approved also for patients who have not received chemotherapy 
Chemohormonal therapy for hormone-sensitive metastatic disease
Castrate-resistant metastatic disease
See the list below:
All patients with metastatic disease become resistant to ADT
Radiation may be used for palliation in patients with painful bone metastases or impending spinal cord compression
Surgical intervention may be necessary for weight-bearing bones involved in pathologic fracture
Therapeutic options are limited, and the focus is on improving quality of life using single or multimodal therapies
Docetaxel every 3 wk plus prednisone is the treatment of choice for men with symptomatic castration-recurrent prostate cancer; [38, 39, 40] recommended dose is docetaxel 75 mg/m2 IV on day 1 plus prednisone 5 mg PO BID; repeat cycle every 21 days for up to a total of 10 cycles (premedicate with oral corticosteroids starting 1 day before docetaxel administration to reduce incidence of hypersensitivity reactions and fluid retention)
Abiraterone (Zytiga) is approved for treatment of patients with metastatic CRPC cancer who are either chemotherapy-naive or who have had prior docetaxel therapy; recommended dose is 1000 mg PO once daily plus prednisone 5 mg PO BID [36, 37, 41, 42] ; in addition, de Bono et al reported that abiraterone prolonged overall survival in patients with metastatic castration-resistant prostate cancer who had received prior chemotherapy. 
An ultramicronized abiraterone tablet (Yonsa) was approved in May 2018 for CRPC in combination with methylprednisolone. The ultramicronized formulation may be administered with or without food, whereas, the original tablet formulation (Zytiga) must be administered 1 hour before or 2 hours after meals.
Abiraterone (Yonsa): 500 mg (four 125-mg ultramicronized tablets) PO daily plus methylprednisolone 4 mg PO BID
Cabazitaxel with prednisone can be used for patients who have hormone-refractory metastatic prostate cancer that was previously treated with a docetaxel-containing treatment regimen; cabazitaxel 25 mg/m2 IV every 3 wk; infuse IV over 1 h; use inline filter (0.22 µm) during administration plus prednisone 10 mg PO daily; reduce cabazitaxel dose to 20 mg/m2 with prolonged or febrile neutropenia or with persistent or severe diarrhea
Treatment recommendations for patients with castration-recurrent prostate cancer and bone metastases
Bisphosphonates are recommended for all men with hormone-refractory prostate cancer and bone metastases [44, 7] Bisphosphonates have been shown to reduce skeleton-related events such as pathologic fracture. Optionss are as follows:
The radiopharmaceutical radium-223 dichloride (Xofigo) is approved for men with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease:
50 kBq (1.36 microcurie) per kg IV infused over 1 minute; repeat q 4 wk for six cycles total; dosage calculation must be based on decay correction factor of radium-223 (listed in prescribing information) 
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Winston W Tan, MD, FACP Associate Professor of Medicine, Mayo Medical School; Consultant and Person-in-Charge of Genitourinary Oncology-Medical Oncology, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic Jacksonville; Vice Chairman of Education, Division of Hematology/Oncology, Mayo Clinic Florida
Winston W Tan, MD, FACP is a member of the following medical societies: American College of Physicians, American Society of Clinical Oncology, American Society of Hematology, Philippine Medical Association, Texas Medical Association
Disclosure: Nothing to disclose.
Mary L Windle, PharmD Adjunct Associate Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference
Disclosure: Nothing to disclose.
Christopher D Braden, DO Hematologist/Oncologist, Chancellor Center for Oncology at Deaconess Hospital; Medical Director, Deaconess Hospital Outpatient Infusion Centers; Chairman, Deaconess Hospital Cancer Committee
Disclosure: Nothing to disclose.
E Jason Abel, MD Associate Professor of Urologic Oncology, Department of Urology, Associate Professor of Radiology (Affiliate Appointment), Department of Radiology, University of Wisconsin School of Medicine and Public Health; Attending Urologist, William S Middleton Memorial Veterans Hospital
E Jason Abel, MD is a member of the following medical societies: American Medical Association, American Society of Clinical Oncology, American Urological Association, Harris County Medical Society, Kidney Cancer Association, Society for Basic Urologic Research, Society of Urologic Oncology, Texas Medical Association
Disclosure: Nothing to disclose.
Reza Ghavamian, MD Professor of Clinical Urology, Albert Einstein College of Medicine; Director of Urologic Oncology, Director of Minimally Invasive and Robotic Urologic Surgery, Montefiore Medical Center
Disclosure: Nothing to disclose.
Prostate Cancer Treatment Protocols
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